Cancer cells, illustration

HOOKIPA Pharma has announced a strategic collaboration and license agreement with Roche to develop its HB-700 immunotherapy for KRAS-mutated cancers and a second undisclosed drug. This is HOOKIPA’s first oncology licensing collaboration. The company is developing a new class of immunotherapies based on its proprietary replicating arenavirus platform.

HOOKIPA will receive $25 million in upfront cash as well as potential future success-based milestone payments up to approximately $930 million for both programs, plus tiered royalties.

KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations.

HB-700 is a replicating two-vector therapy that targets the most common such mutations: G12D, G12V, G12R, G12C and G13D, and thereby could benefit more patients than single mutation inhibitors. Currently available KRAS-targeting drugs, Amgen’s Lumakras (sotorasib) and Mirati’s adagrasib, only target G12C. The biotech estimates that more than 200,000 US and EU patients alone, with just pancreatic, colorectal, and lung indications, could benefit from the treatment.

“We are excited to collaborate with HOOKIPA in leveraging their arenaviral technology, which has clinically demonstrated the ability to induce potent antigen specific CD8+ T cell responses and represents a promising approach for new cancer immunotherapies,” said James Sabry, Global Head of Pharma Partnering at Roche.

“This collaboration further strengthens our leadership in oncology, and we are optimistic about advancing this innovative platform to potentially provide more options for people with KRAS-mutated cancers, as well as other potential cancer types,” he added.

HOOKIPA will conduct research and early clinical development through Phase Ib for HB-700. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval.

“Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers,” said Joern Aldag, chief executive officer at HOOKIPA. “This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new treatments to people with cancer.”

HOOKIPA’s replicating arenaviral technology has demonstrated the ability to induce potent antigen-specific T cell responses and promising anti-tumor activity in a Phase I clinical trial which treated patients with advanced Human Papillomavirus 16-positive head and neck cancers. Preclinical studies have also demonstrated the ability of arenaviral immunotherapies to break self-tolerance and induce potent T cell responses to tumor self-antigens and mutated epitopes, or target parts of a mutated, cancer-causing gene. These findings provide scientific rationale for the HB-700 program.

HOOKIPA’s technologies are engineered to “induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies” the company says. Its pipeline includes wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. In addition to its collaboration with Roche, HOOKIPA is working to develop functional cures of HBV and HIV in collaboration with Gilead.

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